Procedures and strategies for pharmaceutical brands: Norway

By Kristoffer Weltzien, Kathrine Kjendlie and Thomas Gaarder-Olsen, Onsagers AS

Developing and protecting new pharmaceutical product names in Norway is a complex task, requiring experience and know-how at all stages of the process. This chapter outlines key issues to be considered when choosing a new pharmaceutical trademark in Norway.

Selection, clearance and registration

Norway has no separate rules for pharmaceutical trademarks, but the practice of the Norwegian Intellectual Property Office (NIPO) highlights certain points to take into account.

Eligibility depends on the rules set out in the Trademark Act, which is largely based on the EU Trademarks Directive (89/104/EC). For registration eligibility, the mark must have distinctive character, be non-descriptive and not conflict with the public interest. If it contains elements relating to the characteristics or functions of the pharmaceutical product, it is likely to be rejected as descriptive.

The NIPO practises substantive examination and for Class 5 applications will assess the trademark against the World Health Organisation list of registered and proposed international non-proprietary names (INNs). If the trademark application is identical to or an immaterial amendment of an INN , it will be considered descriptive. If the applicant can document that a cited INN is merely proposed – and thus not considered a generic pharmaceutical term – the applicant may overcome the citation.

The NIPO will also assess whether the use of an INN, or an immaterial amendment of an INN, may cause the trademark to be misleading. This could be relevant for applications comprising both a descriptive textual element and a non-descriptive figurative element, after which the entire mark is deemed registrable. The NIPO considers it especially important to prevent trademarks in Class 5 from misleading consumers. For pharmaceutical trademarks that make use of INNs, it may request the list of covered goods to be limited to those containing the relevant active ingredient.

Similarity assessments

Under present NIPO and Norwegian Board of Appeal for Industrial Property Rights (KFIR) practice, a somewhat higher degree of similarity between trademarks is accepted for pharmaceuticals than for other products. The same similarity standards apply to both skilled professionals and private consumers. This is based on the presumption that the average consumer has a relatively high level of attention regarding goods linked to his or her wellbeing.

Pharmaceutical trademarks are rarely limited to prescription products alone. Further, a product first approved under a marketing authorisation as a prescription pharmaceutical may later be approved as an over-the-counter (OTC) product. For these reasons, the similarity assessment should normally take the ordinary consumer into account.

Even though two products with similar trademarks might end up on the same bathroom shelf and thereby increase the risk of a critical product mix-up, this is often not considered during the similarity assessment.

In Norway, several OTC products are approved for sale in grocery stores, petrol stations and other retailers, where the consumer cannot obtain the same guidance as in pharmacies. The similarity assessment might therefore be subject to future change.

Both the NIPO and the KFIR have declared that Norwegian trademark practice should generally be harmonised with EU practice, and case law from the European Court of Justice and the General Court is cited in most KFIR decisions relating to pharmaceutical trademarks. Although few pharmaceutical trademark cases are decided by the Norwegian courts, EU case law is relevant.

Regulation

When selecting trademarks for registered medical products, awareness of the prevailing regulations and requirements set by the Norwegian Medicines Agency (NOMA) is vital. Obtaining a Norwegian trademark registration is not enough; NOMA assessment is obligatory.

As evaluations by medical agencies (including NOMA) are somewhat different from evaluations by the various trademark authorities, it is important to consider and emphasise these criteria as early as possible during the trademark selection process.

In principle, NOMA follows the same regulations and criteria as the European Medicines Agency (EMA). NOMA’s evaluation under a national application for marketing authorisation will be approximately the same as that of the EMA. However, unlike the EMA, NOMA will not provide a pre-evaluation of a trademark.

Sections 3 to 4(b) of the Norwegian Medicinal Directive provide that an application for marketing authorisation must contain the name of the medicinal product.

During the evaluation and approval of a trademark for a registered medical product, NOMA does not take into account NIPO’s assessment. It merely considers the mark in relation to prior approved marketing authorisations and the Medicinal Products Act. A trademark for a registered pharmaceutical product may not:

indicate misleading therapeutic or pharmaceutical properties;

express a commercial message;

indicate a medical disease or – for example – a pain indication;

express or create an association with words with certain established meanings;

mislead regarding the medical compound in the product;

be capable of being confused in print, handwriting or pronunciation with another registered medicinal product;

resemble the generic name; or

contain an INN stem.

Parallel imports and repackaging

Parallel imports are considered a legal form of trade in Norway, in accordance with the EU Treaty, and a trademark owner cannot prevent such trade. Norway has, in accordance with the EU Trademark Directive and case law, accepted regional European Economic Area (EEA) consumption of a trademark right, subject to an assessment of whether legitimate reasons exist to prevent the import.

Such reasons may be that the goods or packaging have been changed or impaired after placing the goods on the market, or that the owner has reasonable grounds to oppose further commercialisation of the product. The main function of the trademark is to guarantee the product’s origin. This cannot be fulfilled if the parallel importer has interfered with the product.

In some cases, repackaging of the parallel imported product may be necessary in order for the importer to gain effective market access. The repackaging must not adversely affect the original condition of the product and will not be considered necessary if undertaken only to secure a commercial advantage for the parallel importer.

A marketing authorisation from NOMA is required for parallel imports of registered medicinal products. Since NOMA generally follows EMA regulations, EMA guidance relating to parallel import is relevant in Norway.

For parallel imports of medicinal specialties authorised through the centralised procedure, NOMA issues a marketing authorisation valid for import from all countries in the European Union and the EEA. Prior notification of the parallel imported product should be sent to the marketing authorisation holder of the product at least one month before the planned import.

Specific regulations govern parallel imports of products under patent protection from certain EU member states. These require notification to the owner or beneficiary of a patent or supplementary protection certificate at least one month before import.

Prior notification of the parallel import will also be sent to the trademark owner.

After years of experience in the medicinal products market, parallel importers are normally aware of the prevailing regulations. However, trademark owners should still establish internal compliance guidelines to check that all regulations and requirements are met, as the trademark owner may in certain cases prohibit the parallel import.

Rights holders should ask for a specimen of the goods immediately on receipt of a notice of parallel import of a product. The parallel importer must comply therewith before placing the parallel imported goods on the market.

As best practice, a parallel importer should also:

check where and by which parties the goods were first placed on the market, and whether this was done with the rights holder’s consent;

check that the names of the manufacturer and parallel importer are clearly printed on the packaging and ascertain that consumers will not be misled to believe that there is a commercial connection between the rights holder and the parallel importer;

ensure that the repackaging of the goods was necessary for effective access to the market and not undertaken solely for commercial advantage, and ascertain that the repackaging has not adversely affected the original product;

check that the parallel imported product has not been sold in defective or poor-quality packages and is not misleading about the producer’s identity. This could easily harm the reputation of the owner of the original trademark; and

consult with its patent department regarding special regulations for certain EU member states.

Anti-counterfeiting and enforcement

Although Norway is outside the European Union, its IP legislation is mainly harmonised with the corresponding legislation in other European countries. However, local legislation regarding customs surveillance and border control is somewhat different.

Customs may, notwithstanding confidentiality, detain goods ex officio and notify the rights holder where it has a reasonable suspicion that the goods constitute an IP infringement. On notification, the rights holder must obtain consent from the importer, or a court order, to have the seized goods destroyed. The importer need not be active in the process: if consent for destruction or a court order is not obtained, the seized goods will usually be released.

However, counterfeit pharmaceutical products are treated differently, as they fall under special legislation for pharmaceuticals. The EU Falsified Pharmaceuticals Directive (2011/62/EC) has been implemented into Norwegian law and came into effect on October 1 2015. While importing pharmaceutical products from the European Union or the EEA for private use was previously permitted, all personal imports of prescription pharmaceuticals are now prohibited.

Private imports of OTC products from EU or EEA countries are still accepted, subject to certain rules:

The quantities must not exceed three months’ personal use.

The products must be legally acquired in the country of purchase.

The seller must be authorised to sell and export the products.

The products must not include narcotics or doping ingredients.

The products must have a valid marketing authorisation in Norway.

Where Customs seizes suspected non-compliant goods, the importer will be given the opportunity to prove that they are compliant. Should insufficient evidence be filed, Customs may destroy the goods without the consent of the importer or a court order.

A rights holder may obtain a general preliminary injunction instructing Customs to detain any suspected infringing goods. To obtain an injunction, the rights holder must establish that there is a risk of infringing goods being imported into the country. The injunction may be based on registered and unregistered rights, in accordance with the Marketing Control Act.

Although IP infringement constitutes a criminal offence and may result in fines and imprisonment, charges are rarely pressed. Cases of counterfeit products being marketed or sold are often resolved amicably or through a preliminary injunction. For pharmaceuticals, most cases of counterfeit products involve customs seizures of privately imported goods bought online. Counterfeit pharmaceuticals rarely hit the Norwegian market.

Advertising

In Norway, advertising of pharmaceutical products must be sober and unbiased, and must not give a misleading or exaggerated impression of the product’s characteristics or medicinal benefits. Advertising may not encourage the use of pharmaceutical products unless medically founded.

Further, advertising is allowed only for registered pharmaceutical products and must comply with the “approved summary of product characteristics”. Norwegian legislation distinguishes between advertising to the general public and advertising to healthcare professionals. Prescription pharmaceuticals may be advertised to healthcare professionals, provided that certain guidelines are met. For example, advertisements with gifts, favours or other contributions attached are prohibited and pharmaceutical samples may be given to medical professionals only after written requisition.

Advertising of prescription medicines to the general public is not allowed. Further, all advertising of pharmaceutical products to children is prohibited, including for nutritional supplements and cosmetic products.

In addition to the legislation, the Association of the Pharmaceutical Industry (LMI) has established the Rules for Marketing of Medicinal Products, based on the Code of Practice adopted by the European Confederation of Pharmaceutical Manufacturers. Members of the LMI are obliged to comply with these detailed rules.

NOMA supervises the marketing of pharmaceuticals, applying a wide definition of ‘advertising’; hence, any kind of written or oral statement, picture or sample which is designed to promote the sale or use of pharmaceutical products is considered as advertising and is subject to NOMA’s scrutiny. NOMA’s supervision can be self-initiated or follow third-party enquiries. In addition, the LMI and NOMA have established the Council for Information on Pharmaceutical Products (CIPP), the industry’s own supervisory body.

Generic substitution

Substitution of an original prescription drug to a generic product with the same active ingredient or a parallel imported product is allowed. However, the product must be approved as substitutional by NOMA. Substitution is permitted only if consistent with the prescriber’s or patient’s explicit preference. If the patient opposes substitution, he or she will have to pay the price difference between the original product and the generic product – which is usually substantial. The main driver here is economic, as original products are normally more expensive than generics.

A list of medicinal products that are considered substitutional is sent to all pharmacies every two months. Before a product is placed on the list of substitutional products, NOMA assesses whether the potentially substitutional products are bioequivalent and medicinally reciprocal. It is possible, although rare, to secure removal of a product from the substitution list if the manufacturer can show studies that clearly prove that the generic product does not have the same effect.

Online issues

The rules on the advertising of pharmaceutical products also apply to online advertising. In addition, all pharmaceutical companies must submit twice-yearly overviews of their own and endorsed websites, including social media content, to the CIPP.

Several minimum requirements apply to such sites. For example, the front page of a website must include certain information open to both the general public and healthcare personnel; the preferred content is neutral information regarding the relevant company. Further, information should be clearly separated for these two groups. Pharmacies may sell OTC pharmaceuticals online, but not prescription products.

Kristoffer Weltzien is a seasoned IP attorney and strategist in IP rights establishment and enforcement, specialising in the chemical and pharmaceutical sectors. Mr Weltzien takes an in-house approach to his client relationships, working in close collaboration with the client to ensure tailor-made advice. He is also a key player in Onsagers’s cooperation with the Confederation of Norwegian Enterprise and frequently speaks at its events. In addition, Mr Weltzien’s eight years’ experience as an examiner with the Norwegian Intellectual Property Office has proved invaluable to international clients seeking advice on prosecution and handling of trademark and design applications in Norway.

Kathrine Kjendlie is a trademark specialist with more than 25 years’ experience, originally as a senior corporate attorney in the pharmaceutical industry and now as part of the Onsagers trademark team. She is a sought-after adviser to pharmaceutical sector clients, but also works with domestic and international companies in other sectors. Her extensive in-house experience – including cooperation with regulatory departments – gives her a particular advantage in understanding pharmaceutical clients’ needs. Ms Kjendlie has managed international pharmaceutical trademark portfolios. She has established global rights to many trademarks for the Takeda group, including trademark creation, availability search and registration procedures. Her work has also encompassed specific trademark strategies, infringements, parallel imports and drafting various trademark agreements.

Thomas Gaarder-Olsen is an attorney at law and partner at Onsagers, assisting domestic and global clients with their trademarks and other IP rights. He is listed as a national trademark expert in Who’s Who Legal. His work ranges from developing IP strategy and establishing IP rights to maintaining and enforcing these rights through dispute resolution and litigation. Mr Gaarder-Olsen has particular experience helping rights holders to fight counterfeiters. In this respect, he has acted as a board member of the Norwegian Anti-counterfeiting Group and enjoys close cooperation with Customs. He is a regular at international trademark conferences, such as the International Trademark Association and the Pharmaceutical Trademarks Group.

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